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For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized: uni-portal and three-portal VATS. In the uniportal approach, the injury on a single intercostal space could determine a lower level of pain than the three-portal approach, allowing a better postoperative course. Few studies in Literature compare these techniques, and most of them are retrospective.
The main purpose of this randomized study is to compare uni-portal VATS with three-portal VATS, in terms of postoperative pain.
Secondary objectives of the study are valutations of:
Randomized cohort clinical trial, prospectic, monocentric. Procedure of randomization: the day before the operation, with the "Random Allocation Rule" technique
Arm 1: pulmonary lobectomy and lymphoadenectomy with uni-portal VATS approach
Arm 2: pulmonary lobectomy and lymphoadenectomy with three-portal VATS approach
Misurations Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.
The choice of cumulative analgesic consumption as parameter of primary outcome is because pain valuation with VAS is significantly affected by individual variability.
Secondary outcomes: measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery. A pain score will be assigned to each patient after the total amount of NRS.
Respiratory function will be valuated with spirometry after 7 and 30 days from surgery, and compared with pre-operative tests.
All intraoperative parameters will be compared between the two groups: operative time (skin to skin), proportion of conversions to open surgery, number of resected lymphnodes, amount of bleeding.
Postoperative complications will be analyzed: rate of prolonged air leaks, surgical site infections, cardiac rythhm disfunctions, pulmonary complications, post-thoracotomy syndrome, as well as lenght of stay at the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uni-portal VATS | VATS uni-portal lobectomy and lymphoadenectomy |
| |
| Three-portal VATS | VATS three-portal lobectomy and lymphoadenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VATS uni-portal lobectomy and lymphoadenectomy | Procedure | VATS uni-portal lobectomy and lymphoadenectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of postoperative pain after uni-portal and three-portal VATS | Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery. | A pain score will be assigned to each patient after the total amount of NRS | 30 days |
| Valuation of respiratory function |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with clinical diagnosis of NSCLC, stage I-II, age 30-75, who undergo pulmonary lobectomy and limphadenectomy with radical intent
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| Name | Affiliation | Role |
|---|---|---|
| Davide Tosi | Fondazione Ca' Granda IRCCS Policlinico Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoracic Surgery Unit - Fondazione IRCCS Ca' Granda Policlinico | Milan | Mi | 20100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33632284 | Derived | Mendogni P, Mazzucco A, Palleschi A, Rosso L, Righi I, Carrinola R, Damarco F, Privitera E, Fumagalli J, Bonitta G, Nosotti M, Tosi D. Uniportal and three-portal video-assisted thoracic surgery pulmonary lobectomy for early-stage lung cancer (UNIT trial): study protocol of a single-center randomized trial. Trials. 2021 Feb 25;22(1):163. doi: 10.1186/s13063-021-05115-w. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| VATS three-portal lobectomy and lymphoadenectomy | Procedure | VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach |
|
Spirometry after 7 and 30 days from surgery, compared with pre-operative tests
| 30 days |
| Intraoperative parameters | Operative time (skin to skin, minutes) | 1 day |
| Intraoperative bleeding | Amount of bleeding | 1 day |
| Postoperative air leakage | Rate of prolonged air leaks | 15 days |
| Postoperative complications | Cardiac rythhm disfunctions | 1 month |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |